OSTEOPLASTY

Tibial plateau, calcaneus and metaphyseal fracture balloon augmentation

 

OSTEOPLASTY kit is a minimally invasive system for the reduction of metaphyseal fractures and bone height restoration, reducing related pain.

The procedure is intended to be used for tibial plateau, calcaneus and distal radius injuries.

The procedure described is indicated for the treatment of patients who have been diagnosed with a tibial plateau depression fracture, according to the Schatzker classification system, corresponding to:

  • TYPE II fractures
  • TYPE III fractures

The system, depending on the fracture type and bone quality, can be used with or without additional plates and/or screws.

 

BENEFITS
  • Totally minimally invasive solution

  • Bone height restoration: gradual and controlled elevation of the area to be treated.

  • Reduced risk of infections

  • Preservation of physiological anatomy and protection of the treated area for any subsequent revisions

  • Fast recovery after treatment

  • Ready-to-use bone substitute:
      • No preparation needed
      • Hardening in wet environment only: no time pressure during application
      • Truly biologic: composed by a micro-crystalline, calcium deficient hydroxyapatite – major bone constituent
      • High load sharing properties (up to 45 MPa)
      • Radio-opaque paste: clearly visible under fluoroscopy and X-rays
      • Bioresorbable during bone remodeling

APPLICATION

  • TIBIAL PLATEAU FRACTURES

  • PROXIMAL HUMERUS FRACTURES

  • HEEL FRACTURES

  • DISTAL RADIUS FRACTURES

COMPONENTS

– WORKING CANNULA with trocar tip stylet

made by an external cannula used as working channel and an internal stylet with trocar tip to access the subchondral bone. The needle has a plastic handle.

TROCAR TIP

– DRILL

composed by a metal part with distal bone drill (screwed terminal portion) and a plastic handle. This device is used to dig into the bone to target the area to be treated.

DRILL TIP

– BONE FILLER

is a cement infusion cannula (often referred to as the “filler” cannula) and consists of a steel cannula with a plastic handle, that is filled with cement outside the patient and then introduced through the working channel already inserted in the patient, during the procedure. The device is equipped with a pusher stylet that allows the gradual introduction of the cement into the target area. The plastic handle has a universal luer lock connection for the filling of the cannula with bone cement. Also dedicated injection syringes with luer lock connection are present in the kit.

BONE FILLER TIP

– BALLOON CATHETER
available sizes 10mm – 15 mm – 20 mm

is a single-use catheter with a balloon at the distal end. The catheter has two separate lumens connected to a connector with side way in correspondence to the proximal end of the catheter. The external lumen is used to inflate the balloon and the central lumen contains a stylet used to facilitate the insertion of the balloon catheter. The device also has radiopaque markers. The balloon has been designed to be inflated to a certain pressure; the correct pressure to apply is indicated on the package label and here below.

– BIOLOGICAL CEMENT

  • truly biological
  • ready-to-use: “tooth paste” consistence
  • no time pressure: “infinite” working time
  • hardening in wet environment only
  • radio-opaque
  • bioresorbable

– DIGITAL INFLATION DEVICE

SURGICAL TECHNIQUE

1. Identify the best surgical trajectory
2. MIS access to the entry point through cannula and trocar stylet under fluoroscopic guidance
3. Remove the stylet from the cannula and insert the drill under the depressed area of bone
4. After removing the drill insert and inflate the inflatable balloon catheter through the cannula centered to the area of depressed fragments
5. Once the injury has been adequately reduced, deflate and remove the catheter balloon from the cannula
6. Fill the cavity created with bone substitute until the void is completely filled under fluoroscopic guidance
7. Plating may be performed before or after the filling of bone substitute

RELATED PRODUCTs

ORTHOPLASTY

Subchondral bone plasty

MARROW-STEM

Bone marrow MSCs aspiration kit

 

LIPO-STEM

Adipose-derived MSCs purification kit